Trial Outcomes & Findings for A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver (NCT NCT00803647)

NCT ID: NCT00803647

Last Updated: 2021-10-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 8 months
• Results posted on: 2021-10-06

Participant Flow

Participant milestones

Measure	Treatment mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver

Baseline characteristics by cohort

Measure	Treatment n=20 Participants mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Age, Continuous	52.8 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex/Gender, Customized	NA participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 months

Population: All 20 patients were included in this outcome measure.

Outcome measures

Measure	Treatment n=20 Participants mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
The Percentage of Patients Who Had a Curative (R0) Liver Metastasectomy Following Protocol Treatment, i.e., Metastatic Disease That Can be Completely Resected and/or Ablated With no Postoperative Evidence of Residual Malignant Disease (R0 Resection).	75 percentage of participants Interval 50.9 to 91.34

PRIMARY outcome

Timeframe: 8 months

19 participants experienced at least one adverse event. There were a total of 95 adverse events reported. (Note: multiple occurrences of the same adverse event in one individual are counted only once.) Refer to the Adverse Events section for specifics. The Other Adverse Events section lists only those events occurring above 5% frequency.

Outcome measures

Measure	Treatment n=20 Participants mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Reported Adverse Events.	95 adverse events

SECONDARY outcome

Timeframe: 18 months

The percentage of patients alive at 18 months.

Outcome measures

Measure	Treatment n=20 Participants mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Overall Survival (OS). Time From Study Entry Until Death From Any Cause.	83.8 percentage of participants Interval 57.7 to 94.5

SECONDARY outcome

Timeframe: 8 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by PET/CT, CT scan, MRI or spiral CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective clinical Response Rate (cRR) = CR + PR during the 3 preoperative cycles, among the treated patients.

Outcome measures

Measure	Treatment n=20 Participants mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Objective Clinical Response Rate (cRR). Measureable Lesions That Can be Accurately Measured in at Least One Dimension With Conventional Radiologic Techniques or Spiral CT.	85 percentage of participants Interval 62.1 to 96.8

SECONDARY outcome

Timeframe: 2 years

Population: Patients with R0 resection

Outcome measures

Measure	Treatment n=15 Participants mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Recurrence-free Survival (RFS). Time From Study Entry Until First Recurrence.	13.3 months Interval 5.5 to 23.2

Adverse Events

Treatment

Serious events: 6 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=20 participants at risk mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Infections and infestations septic shock	5.0% 1/20 • Number of events 1 • 8 months
Infections and infestations wound infection	5.0% 1/20 • Number of events 1 • 8 months
Injury, poisoning and procedural complications vascular access complication	10.0% 2/20 • Number of events 2 • 8 months
Respiratory, thoracic and mediastinal disorders acute respiratory distress syndrome	5.0% 1/20 • Number of events 1 • 8 months
Blood and lymphatic system disorders anaemia	5.0% 1/20 • Number of events 1 • 8 months
Cardiac disorders arhythmia supraventricular	5.0% 1/20 • Number of events 1 • 8 months
Gastrointestinal disorders upper gastrointestinal haemorrhage	5.0% 1/20 • Number of events 1 • 8 months
General disorders thrombosis in device	5.0% 1/20 • Number of events 1 • 8 months
Hepatobiliary disorders hyperbilirubinaemia	5.0% 1/20 • Number of events 1 • 8 months
Investigations platelet count decreased	5.0% 1/20 • Number of events 1 • 8 months
Vascular disorders deep vein thrombosis	5.0% 1/20 • Number of events 1 • 8 months
Vascular disorders venous thrombosis	5.0% 1/20 • Number of events 1 • 8 months
Infections and infestations Cavernous sinus thrombosis	5.0% 1/20 • Number of events 1 • 8 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.0% 1/20 • Number of events 1 • 8 months

Other adverse events

Measure	Treatment n=20 participants at risk mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Investigations alanine aminotransferase increased	10.0% 2/20 • Number of events 2 • 8 months
Investigations aspartate aminotransferase increased	10.0% 2/20 • Number of events 2 • 8 months
Investigations blood alkaline phosphatase increased	10.0% 2/20 • Number of events 2 • 8 months
Skin and subcutaneous tissue disorders exfoliative rash	30.0% 6/20 • Number of events 6 • 8 months
Skin and subcutaneous tissue disorders dermatitis acneiform	20.0% 4/20 • Number of events 4 • 8 months
Skin and subcutaneous tissue disorders rash	10.0% 2/20 • Number of events 2 • 8 months
Blood and lymphatic system disorders neutropenia	35.0% 7/20 • Number of events 7 • 8 months
Blood and lymphatic system disorders anaemia	15.0% 3/20 • Number of events 3 • 8 months
Blood and lymphatic system disorders leukopenia	15.0% 3/20 • Number of events 3 • 8 months
Blood and lymphatic system disorders lymphopenia	10.0% 2/20 • Number of events 2 • 8 months
Metabolism and nutrition disorders decreased appetitie	10.0% 2/20 • Number of events 2 • 8 months
Metabolism and nutrition disorders hyperglycaemia	10.0% 2/20 • Number of events 2 • 8 months
Metabolism and nutrition disorders hypoalbuminaemia	10.0% 2/20 • Number of events 2 • 8 months
Nervous system disorders peripheral sensory neuropathy	15.0% 3/20 • Number of events 3 • 8 months
General disorders fatigue	10.0% 2/20 • Number of events 2 • 8 months
Immune system disorders hypersensitivity	15.0% 3/20 • Number of events 3 • 8 months

Additional Information

Diana Gosik, Director Department of Site and Study Management

NSABP Foundation

Phone: 412-339-5333

Email: diana.gosik@nsabp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60